A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Launched by NOVARTIS PHARMACEUTICALS · Sep 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a drug called iptacopan, which is being tested for its long-term safety and tolerability in people with a kidney condition known as primary IgA nephropathy. Participants in this study are those who have previously completed related studies and are now given the chance to continue receiving iptacopan until it becomes available for general use. The trial is designed to gather information on how well the drug works over time and to monitor any side effects.

To be eligible, participants need to be between 65 and 74 years old, have a specific level of kidney function, and be on a supportive care regimen. They should also have received vaccinations against certain infections. People with certain kidney issues, severe urinary problems, or those currently taking specific medications may not qualify for the study. Those who join can expect regular check-ups every six months to assess how they are doing with the treatment. This trial is an important step in understanding how iptacopan can help manage primary IgA nephropathy in the long run.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
• • eGFR\* ≥ 20 ml/min/1.73m2
• • \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
• • Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
• • Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
• • All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.
• • participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
• Exclusion Criteria:
• • participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
• • Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
• • Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
• • Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
• • Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
• • Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
• • History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.